|
Device | ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM |
Generic Name | Stimulator, electrical, implanted, for parkinsonian tremor |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S220 |
Date Received | 02/27/2015 |
Decision Date | 05/11/2015 |
Product Codes |
MHY NHL |
Advisory Committee |
Neurology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MATERIAL CHANGES TO TWO NON-IMPLANTABLE SCREENING CABLES (THE ALLIGATOR CLIP SCREENING CABLE ACCESSORY KIT AND THE TWIST LOCK SCREENING CABLE ACCESSORY KIT) TO COMPLY WITH THE EUROPEAN UNION RESTRICTION OF HAZARDOUS SUBSTANCES II DIRECTIVE 2011/65/EU. |
Post-Approval Study | Show Report Schedule and Study Progress |